Clinical trial on paraxanthine (PX) in comparison to that of caffeine (CF) in otherwise healthy volunteers

A prospective, double-blind, randomized, cross-over, four arm, four treatments, two period, placebo-controlled study to evaluate the taste, memory/cognition and anxiety effects of 2 different doses of paraxanthine (PX) in comparison to that of caffeine (CF) in otherwise healthy volunteers

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/03/041219

Enrollment

Registered

2022-03-21

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Period I: Decaffeinated beverage plus 50mg Caffeine: Dose : 50mg Dosage form: Powder Route of Administration: orally Frequency :once daily on Day 1 to Day 7 Intervention2: Period I: D

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subject has provided written and dated informed consent to participate in the study. 2.Subject is willing and able to comply with the protocol. 3.Subject is a male/female between 18 and 55 years of age.

Exclusion criteria

Exclusion criteria: 1. Subject is a slow caffeine metabolizer [determined by genome testing regarding the enzyme in the liver that metabolizes caffeine, p450 1A2 (CYP1A2)]. 2. Subject is participating in another clinical trial or has received an investigational product within thirty days prior to enrollment. 3. Subject has a history of alcohol or other drug abuse in the past year. 4. Subject has a significant history or current presence of treated or untreated bleeding disorder, diabetes mellitus, high blood pressure (BP) [systolic BP > 140 and/or diastolic BP > 90], thyroid disease, tachyarrhythmia, heart disease, kidney disease, or liver disease. 5. Subject currently suffers from a sleep disorder and/or has a known history of (or is currently being treated for) clinical anxiety, eating disorder(s) or any other psychiatric condition(s), which in the opinion of the investigator, might put the subject at risk and/or confound the results of the study. 6. Subject has a known allergy or sensitivity to any ingredient in the test product. 7. Subject has any medical condition or uses any medication, nutritional product, dietary supplement or program, which in the opinion of the investigator, might interfere with the conduct of the study or place the subject at risk. 8. Investigator is uncertain about subjectÃ¢â?¬•s capability or willingness to comply with the protocol requirements.

Design outcomes

Primary

Measure	Time frame
1. The % change in the taste as perceived by the feedback from average number of subjects (from Day 0 to Day 7) between same strengths of PX and CF and also with respective placebo groups. 2. The % change in the memory/cognition enhancement as perceived by the questionnaires and biomarkers between same strengths of PX and CF and also with respective placebo groups (from Day 0 to Day 7). 3. The % change in the anxiety as perceived by the questionnaires and biomarkers between same strengths of PX and CF and also with respective placebo groups (from Day 0 to Day 7). 4. The % change in the vital parameters between same strengths of PX and CF and also with respective placebo groups (from Day 0 to Day 7). Timepoint: Day 0 to Day 7	—

Measure

Time frame

1. The % change in the taste as perceived by the feedback from average number of subjects (from Day 0 to Day 7) between same strengths of PX and CF and also with respective placebo groups. 2. The % change in the memory/cognition enhancement as perceived by the questionnaires and biomarkers between same strengths of PX and CF and also with respective placebo groups (from Day 0 to Day 7). 3. The % change in the anxiety as perceived by the questionnaires and biomarkers between same strengths of PX and CF and also with respective placebo groups (from Day 0 to Day 7). 4. The % change in the vital parameters between same strengths of PX and CF and also with respective placebo groups (from Day 0 to Day 7). Timepoint: Day 0 to Day 7

—

Secondary

Measure	Time frame
Adverse eventsTimepoint: Day 0 to Day 21	—

Countries

India

Contacts

Public ContactDr Ashok Godavarthi

Radiant Research Services Pvt Ltd

ashok@radiantresearch.in9880999297

Outcome results